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Senior Quality Assurance Engineer

2 months ago

Singapore EA RECRUITMENT PTE. LTD. Full time
Job Title: Senior / Quality Engineer X 2 (Quality Control / ISO 13485 / Medical Devices / Healthcare)

We are seeking a highly skilled Senior / Quality Engineer to join our team at EA Recruitment Pte Ltd. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our medical devices.

Key Responsibilities:
  • Conduct thorough assessments and reviews of supplier qualifications, performance, and process capabilities to ensure compliance with ISO 13485 standards.
  • Identify and address quality issues, analyze root causes, and implement corrective actions to prevent recurrence.
  • Collect, handle, and follow up on customer feedback and complaints to ensure timely resolution and continuous improvement.
  • Support internal and external audits, including ISO 13485 audits, to ensure compliance and identify areas for improvement.
  • Evaluate, verify, and validate new parts and samples to ensure they meet quality standards.
  • Establish and maintain inspection criteria for incoming, in-process, and final products to ensure quality and consistency.
  • Authorize the release of products, review and approve COA, and drive continuous improvement initiatives.
  • Analyze monthly data on product quality and quality objectives to identify trends and areas for improvement.
  • Review and approve DHR documents to ensure compliance with quality standards.
  • Participate in new project initiatives, commercial product quality management, and control to ensure quality and compliance.
  • Drive change management and control initiatives to ensure smooth transitions and minimal disruption to operations.
Requirements:
  • Possess a minimum Diploma/Degree in a relevant subject area with 3 years' experience in medical device QA and/or RA.
  • ISO 13485:2016 certified internal auditor will be advantageous.
  • Familiarity with quality control tools and processes.

Candidates are encouraged to apply for this position with a comprehensive resume that includes work experiences, job responsibilities, current and expected salary, reason for leaving, date of availability, and education background.

Only shortlisted candidates will be contacted.